Prussian blue

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Jul 2010 - 18 Jan 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Országos Gyógyszerészeti Intézet, National Institute of Pharmacy, Budapest, Hungary

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)

EC Number:

247-304-1

EC Name:

Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)

Cas Number:

25869-00-5

Molecular formula:

C6FeN6H4N

IUPAC Name:

Ammonium Iron(3+) Hexakis(Cyano-C)Ferrate(4-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): ammonium iron(3+) hexakis(cyano-C)ferrate(4-)
- Physical state: solid
- Appearance: blue odourless powder
- Analytical purity: 93.6%
- Lot/batch No.: K73-4766
- Expiration date of the lot/batch: 20 Mar 2013
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rat

Strain:

other: Wistar CRL:(WI)BR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 183 - 202 g
- Fasting period before study: Animals were fasted over night before until 3 h after test substance application.
- Housing: Groups of 3 animals were housed in Type II polypropylene/polycarbonate cages with lignocell bedding.
- Diet: ssniff® SM R/M-Z+H Autoclavable complete food for rats and mice - breeding and maintenance, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 -26.1
- Humidity (%): 41 - 75
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 22 Jul 2010
To: 05 Aug 2010
From: 27 Jul 2010
To: 10 Aug 2010
From: 28 Jul 2010
To: 11 Aug 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no.: 07K05 7

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the absence of any acute toxicity data, a starting dose of 300 mg/kg bw according to OECD 423 was chosen by the study director.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg bw: 3 females
2000 mg/kg bw: 6 females

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 0.5, 1, 2, 3, 4 and 6 h after application of the test substance and daily thereafter. The body weight of each animal was recorded on the day before treatment, on the treatment day and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off according to OECD 423

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: experimental result

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14 d observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified